The plasma clearance of montelukast averages 45 mL/min in healthy adults. 937-38.Montelukast sodium. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. In placebo-controlled clinical trials, the following event was reported with SINGULAIR with a frequency ≥1% and at an incidence greater than placebo, regardless of causality assessment: upper respiratory infection, 1.9% of patients receiving SINGULAIR vs. 1.5% of patients receiving placebo. The side effects in patients treated with SINGULAIR were similar in type and frequency to side effects in patients who were given a placebo (a pill containing no medicine).The most common side effects with SINGULAIR include:Less common side effects that have happened with SINGULAIR include:Behavior and mood-related changes have been reported: agitation including aggressive behavior or hostility, bad/vivid dreams, depression, feeling anxious, hallucinations (seeing things that are not there), irritability, restlessness, sleep walking, suicidal thoughts and actions (including suicide), tremor, trouble sleeping. SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction in patients 15 years of age and older.SINGULAIR is indicated for the relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older, and perennial allergic rhinitis in adults and pediatric patients 6 months of age and older).

In the study in which efficacy was demonstrated, SINGULAIR 10-mg tablets once daily was shown to significantly reduce symptoms of perennial allergic rhinitis over a 6-week treatment period (TABLE 5); in this study the primary outcome variable was mean change from baseline in daytime nasal symptoms score (the average of individual scores of nasal congestion, rhinorrhea, and sneezing). Daily administration of SINGULAIR for the chronic treatment of asthma has not been established to prevent acute episodes of exercise-induced bronchoconstriction.For allergic rhinitis SINGULAIR should be taken once daily.

But, if you are taking it to avoid breathing difficulties during exercise, it should be taken 2 hours before exercise.It can be directly given in the mouth or dissolve in 1 teaspoonful of cold or room temperature baby formula or breast milk. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy.

One may also experience depression and suicidal tendency. Each 10-mg film-coated SINGULAIR tablet contains 10.4 mg montelukast sodium, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The period of randomized treatment was 2 weeks in 4 trials and 4 weeks in one trial. Safety and effectiveness in pediatric patients less than 12 months of age have not been established.For prevention of EIB, a single dose of SINGULAIR should be taken at least 2 hours before exercise.

Be sure that the entire dose is mixed with the food, baby formula, or breast milk and that the child is given the entire spoonful of the food, baby formula, or breast milk mixture right away (within 15 minutes).If you have asthma and if your asthma is made worse by aspirin, continue to avoid aspirin or other medicines called non-steroidal anti-inflammatory drugs while taking SINGULAIR.The side effects of SINGULAIR are usually mild, and generally did not cause patients to stop taking their medicine.

SINGULAIR administered once daily was generally well tolerated, with a safety profile consistent with that observed in patients with seasonal allergic rhinitis and similar to that of placebo.